RU2492877C2 - Inhaler comprising carrier having large number of hermetic cavities containing drug preparation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to versions of an inhaler, and a method of operation thereof. The inhaler comprises a carrier having series sealed cavities containing a drug preparation. To seal the drug preparation inside the respective cavities coupled to the carrier, a foil is attached to the carrier. Spacer elements each of which is coupled to the respective cavity and designed to separate the foil from the cavity are attached to the other side of the foil. Each spacer element can be moved from the coupled cavity by separating the sealing foil from the cavity which thereby opens to make the drug preparation be captured by the fluid flow; the spacer element with the attached foil is then placed back to seal the coupled cavity.

EFFECT: group of inventions enables using the opening element as a closing element also to prevent the powder residuals escaping from the cavity.

19 cl, 6 dwg

Description

FIELD OF TECHNOLOGY

The present invention relates to an inhaler containing a base having at least one cavity containing a drug, such as in the form of a dry powdered drug. The present invention also relates to a method associated with such an inhaler.

BACKGROUND OF THE INVENTION

There are various types of inhalers on the market. Pressure Dosing Inhaler (pMDI) releases a fixed dose of the substance in the form of an aerosol. A powder inhaler typically releases a dose of a powdery substance trapped in an air stream. In a powder inhaler, the powder agent may be located in a volumetric container of the inhaler, from which doses of the powder agent are measured to dispense. As an alternative to a bulk container, powdered inhalers may contain one compartment or several compartments for containing discrete doses of the powdered substance. Such compartments may be in the form of sealed blisters in a blister pack containing cavity cavities connected to a sealing strip or other suitable shapes.

There are various solutions for opening compartments containing discrete doses of a powdered product. International Patent Application No. 01/72605 discloses various embodiments of a metering strip for use with a powder inhaler. Various autopsy mechanisms are disclosed. For example, in Figure 4 of this application, a strip in the form of a cover closes blisters located at a distance from each other. The tear-off tabs of the lid are attached to a lid-shaped strip on top of each blister. A tear strip is connected to each tear tab of the lid. The separation of the tear strip opens blisters. In FIG. 22 of international patent application No. 01/72605, the metering strip contains a number of blisters containing a pharmaceutical powder. Each blister is connected to a corresponding piston. The blister is opened with a slider with a wedge that interacts with the groove on the piston. The wedge pulls the piston down, breaking the seal and releasing the pharmaceutical powdery agent into the flow channel for inhalation.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an alternative method of performing operations with sealed compartments or cavities and elements associated with them in an inhaler. This and other objectives, which will become apparent from the following description, are achieved by the invention defined in the attached claims.

The present invention is based on the understanding that the opening element can be made with dual functionality. Thus, both after and before use for opening the sealed compartment containing the powdery means, this element can perform a different function than the opening function. In particular, it has become clear that the opening element can be made in the form of an element forming a flow channel for directing the flow of fluid. It also became clear that the opening element can subsequently function as a closing element to prevent the possible residues of the powdery agent from leaving the used compartment.

In accordance with at least a first aspect of the invention, there is provided an inhaler comprising

a base having sealed cavities containing the drug, which are arranged to move sequentially to the position of the distribution of the inhaler,

foil, which is attached to the base on one side for hermetically closing the medicinal product inside the corresponding associated cavities, and on the opposite side is attached to the separation elements, each of which is associated with the corresponding cavity and is designed to separate the foil from this cavity,

a drive configured to act on the separation element associated with the cavity that is currently located in the dispensing position, thereby moving this separation element to a position remote from the cavity in which the separation element is spaced from the cavity to allow the sealing to separate foil from the cavity, which, thus, opens with the possibility of capturing the contained medicinal product in the fluid stream,

however, when the separation element is in a position remote from the cavity, the attached foil at least partially limits the flow channel for the drug captured from the cavity.

Thus, the separation element is not ejected when it is used to open the sealed cavity. On the contrary, it now functions as an element forming the flow channel along with the attached foil.

According to at least one illustrative embodiment, the spacer element has a return position in which the spacer element with the foil attached is returned to close its corresponding cavity. Thus, the separation element is not ejected after it has caused the foil to separate from the cavity, but can be returned to close this cavity after the fluid stream has captured the powdery means from this cavity. Such closure will prevent any powdery substance remaining in the cavity from exiting the closed used cavity, thereby reducing the risk of dose fluctuation that may occur if such powdery substance remaining in the cavity is captured during the next inhalation. It also reduces the risk of the remaining powdery agent leaving the cavity and interfering with the mechanical elements in the inhaler, or making a rattling sound that is undesirable for the user.

Although the inhaler may suitably be a single dose inhalation device, the teachings of the present invention may also be implemented in a multiple dose inhalation device. Thus, in accordance with at least one illustrative embodiment, the base has a large number of sequentially sealed cavities containing a drug, each cavity being hermetically closed by a corresponding foil associated with it, each foil being attached to the separating element with its other side, associated with the corresponding cavity and designed to separate the foil from this cavity.

It is solely for the purpose of explanation in the following description that the inhaler is oriented in such a way that the cavities are located below the foil and that the spacer elements are located above the foil. Thus, any expressions associated with a direction or orientation, such as “top,” “side,” “above,” “below,” are used herein with reference to the inhaler orientation just indicated. However, it should be understood that this definition is used only for a simple description and, thus, the inhaler made in accordance with the invention is not limited to a specific orientation. For simplicity and unnecessary repetition, the discussion that follows focuses mainly on a multiple dose inhalation device. However, it should be understood that at least some of the features discussed are also applicable to a single dose inhalation device.

In accordance with at least an embodiment of the invention, there is provided an inhaler comprising a base having hermetically sealed cavities containing a drug, which are arranged to move sequentially to the distribution position of the inhaler,

foil, which is attached to the base on one side for hermetically closing the medicinal product inside the corresponding cavities associated with it, and on the opposite side is attached to the separation elements, each of which is associated with the corresponding cavity and is designed to separate the foil from this cavity,

a drive configured to act on the separation element associated with the cavity, currently located in the dispensing position, thereby moving this separation element to a position remote from the cavity, in which the separation element is spaced apart from the cavity to ensure separation of the sealing foil from the cavity, which, thus, opens with the possibility of capturing the contained medicinal product in the fluid stream,

moreover, the cavity is made with the possibility of stepwise movement relative to the drive.

For a multiple-dose inhalation device, it became clear that the separation element could be used to form various flow channels associated with different cavities. Accordingly, instead of obstructing the flow channel during subsequent inhalations, the spacer element can actually be used to at least partially form the various flow channels. Thus, in accordance with at least one illustrative embodiment, each spacer element comprises a first wall to which a foil is attached to at least partially form a flow channel for an associated cavity, and a second wall for at least partially form a flow channel for adjacent cavity. Thus, it should be understood that this illustrative embodiment can be used in connection with an inhaler containing a large number of cavities having separate flow channels. As soon as the separation element is removed from the base to allow inhalation, this will not interfere with subsequent inhalation, since the next cavity has its own flow channel. Thus, instead of becoming an obstacle after its first use, this element promotes second use by restricting another flow channel to another cavity.

Although said first and second walls of the separation element may be located on the same side (for example, due to possible rotation of the separation element), these walls are suitably located on different sides of the separation element. This is suitable for creating separate flow channels for cavities. Thus, avoiding the use of the same wall twice, the risk that the remaining powdery agent adhering to such a wall will be entrapped in the subsequent inhalation stream is significantly reduced. Typically, the first wall will face a cavity associated with it, which is located below the first wall, thereby forming the upper wall of the formation of the flow channel to the associated cavity, when it is raised from the cavity. Typically, the second wall is at least somewhat perpendicular to said first wall, with the possibility, thereby, of forming a side wall of the formation of a flow channel with an adjacent cavity.

When the spacer member is spaced a distance from its associated cavity to remove the foil and open the cavity, the foil remains attached to the spacer element. Thus, the removed foil becomes part of the first wall to form a flow channel.

Parts of the foil can be made as a single foil and, optionally, parts of the foil can be formed by perforations or other weakenings in the material. As an alternative to a single foil, parts of the foil can be made in the form of individual pieces. Parts of the foil may be attached to the base and spacer elements by welding, gluing, or other suitable method. It should be noted that the terms “foil” and “part of the foil” are not limited to one layer of material. In contrast, the foil or part of the foil may contain a large number of layers. For example, the foil may contain a metal layer that is coated with varnish or a polymer layer on one or both sides in any suitable combination to provide the required rigidity, attachment ability, etc.

In accordance with at least one illustrative embodiment of the invention, each spacer element comprises a third wall for at least partially forming a flow channel for another adjacent cavity on the other side of the associated cavity. Typically, this third wall will be at least somewhat perpendicular to said first wall, with the possibility thereby of forming a side wall to form a flow channel with said other adjacent cavity.

As mentioned earlier, although it is possible that the dividing elements can be moved in such a way that the wall performs the function of forming a flow channel for more than one cavity, it is natural that for each of these walls its functions of forming the flow channel are performed only with respect to one corresponding cavity . Thus, for example, the first wall of the selected separation element may partially limit the flow channel for the powder means in the cavity below the separation element, while the second and third walls may partially limit the flow channels for two adjacent cavities located, respectively, to the left and right of the separation element .

As mentioned above, the separation element can be moved away from its associated cavity to separate the corresponding foil from the specified cavity and create the upper wall of the formation of the flow channel. The spacer elements which are adjacent to said retracted spacer element can also form a part for forming a flow channel, usually as side walls of a flow channel formation. This is reflected in at least one illustrative embodiment of the invention, wherein said fluid stream is guided by a flow channel that is at least partially formed by first, second and third successive separation elements, with only the intermediate second separation element being in said position remote from the cavity . In other words, each separation element has a first position in which it covers the opening of the cavity associated with it, and a second position (referred to above as the “distant position”), in which it is distant some distance from the cavity and allows the fluid flow to capture the drug a remedy from the cavity. Thus, the first position is both the initial position (i.e., the state in which the foil is still attached before removing the separation member) and the above-mentioned return position (i.e., after the separation member has been removed in order to move with a foil, and then returned).

It should be noted that the dividing elements can return from the second (distant) position to the first (return) position in order to function as a side wall of the formation of the flow channel for the adjacent cavity. As an example, it can be assumed that there are three consecutive cavities: a first cavity having a first separation element connected thereto, a second cavity having a second separation element connected to it, and a third cavity having a third separation element connected to it. The second separation element may then initially function as the side wall of the formation of the flow channel for the fluid flow, which captures the powdery means from the first cavity (when it is opened). Then, the second separation element can be moved away from its associated second cavity to function as the upper wall of the formation of the flow channel for the fluid flow, which captures the powdery means from the second cavity thus opened. Finally, the second separation element can be moved back to its associated second cavity to function as a side wall of the formation of a flow channel for a fluid stream that captures the powdery means from the third cavity (when it is opened).

The multifunctionality of the spacer element illustrated above is at least partially reflected in at least one illustrative embodiment of the invention in which each spacer element has a first (initial or return) position in which it closes an opening of a cavity associated with it and a second (distant) position in which it is distant at a certain distance from the cavity, each of these separation elements being in said second (distant) position, in which he at least partially forms a flow channel for the flow of fluid to capture the drug from the cavity associated with it, and in the specified first (initial or return) position, together with an adjacent separation element located in the specified second position, in which it is at least partially forms a flow channel for the fluid flow to capture the drug from the cavity associated with the specified adjacent separation element.

Although it has been described above that the dividing element can at least partially form a side wall for forming a flow channel for an adjacent cavity, it is alternatively possible to provide fixed side elements for forming a flow channel. According to at least one illustrative embodiment of the invention, a separation wall is provided between each pair of adjacent dividing elements, which extends perpendicularly upward from the base. In this case, there will be two lateral dividing walls that contribute to the formation of a flow channel, one on each side of the cavity (if you look in the direction of fluid flow), while the dividing element associated with this cavity, when it is raised, will form the upper wall of the flow channel. Assembled together, the separation walls can be mounted on the foil, which closes (or is intended to close) the cavity in a manner that causes weakening in the foil, thereby forming limited portions of the foil between the separation walls.

In accordance with at least one illustrative embodiment of the invention, each spacer element comprises a drive accommodating portion, the inhaler comprising a actuator configured to exert force on the host drive portion to allow the separation elements to move from said first position to said second position. The opening force can be directed from below and can push the enclosing drive part up. Alternatively, an opening force can be achieved by providing an upper tensile force acting on the part accommodating the drive. Thus, depending on the direction of the force and the drive providing the force, the part accommodating the drive can be made in various ways, for example, by protrusions, staples, hooks, recesses, consoles, channels, etc.

In order to separate the foil from the cavity that it seals tightly, the foil must be appropriately attached to the separating element associated with it. According to at least one illustrative embodiment of the invention, the fastening force between the spacer elements and the associated associated foil is greater than the fastening force between the base and the foil, as a result of which the movement of such a spacer from the associated cavity leads to the separation of the associated him foil from the base.

Accordingly, the contact area between the foil and the connected separating element connected thereto is such that no foil interfering with the flow is interrupted after separation. In other words, the flow channel downstream and upstream of the cavity opening should be free of any obstructing foil edges. Accordingly, on the base, the flow channel upstream and downstream of the cavity opening is completely free of foil after separation has occurred. This can be achieved by making the separation element with longer (or the same) protrusions in the direction of the flow channel, compared with the foil. Since the foil extends across the opening of the cavity in order to seal the cavity, the attached separation element must also extend at least across the opening of the cavity. As mentioned previously, the foil may form part of a single closing foil having perforations or loosening that bound the foil. Such perforations in this case are between the holes of the cavity, and when the foil is torn along these perforations or weakenings, any edges will be located sideways from the cavity when viewed in the direction of flow and, therefore, no interfering edges will be present upstream or downstream flow from the cavity.

There are various ways to obtain a fastening force at a separation element / foil interface of a larger magnitude than at a foil / base interface. According to at least one illustrative embodiment of the invention, the contact surface between the spacer element and the associated foil is larger than the contact surface between this foil and the base. In other words, the separator / foil interface is larger than the foil / base interface. If the separating element covers the entire foil, the contact surface between the separating element and the foil will automatically be larger than the contact surface between the foil and the base, since the foil located directly above the cavity opening is not attached to anything, but only the surrounding area of the foil is attached to the base .

Another way to obtain different fastening forces is discussed in at least one other illustrative embodiment of the invention. The foil may comprise a first coating layer to which the base is attached and a second coating layer to which the spacer elements are attached, the tensile strength of the second coating layer being greater than the tensile strength of the first coating layer. The layers can provide various adhesive properties, for example, for welding various types of material, or adhesives of various types or quantities, or any combination thereof.

Other ways to obtain a difference in fastening forces may consist in making the spacer element with specially designed geometric elements, for example grooves to which the foil can be attached, or other elements that, for example, pierce the foil to create a stable grip.

Although the foil can be folded into the grooves of the separation element or otherwise curved around the separation element, for example, to increase the attachment area, the foil can accordingly only be flat, that is, extend only in one plane parallel to the plane of the base. This makes it possible to easily attach the spacer elements to the foil. When they are assembled, the foil can be attached to the base. Alternatively, you can first attach the foil to the base, and then attach the spacer elements to their respective parts of the foil.

Accordingly, the stiffness of the dividing elements is substantially greater than the stiffness of the foil, while the dividing elements provide the ability to move the foil as a whole and therefore they can be disconnected from the base and not peeled off.

Although a single cavity having one associated dividing element has been described in the above illustrative embodiments, alternatively, there may be two cavities having one common dividing element associated with them. For example, if two incompatible components of a drug must be inhaled essentially simultaneously, then they, respectively, must be placed in two separate cavities. These two cavities can be closed and sealed with one common foil (or each cavity with its own foil), which, in turn, is attached to a common separating element extending across both cavities. Thus, when the separation element moves away from the cavity, it moves the foil with it, revealing both cavities, from which the components of the drug can be captured in the inhaled stream. The cavities can either be arranged sequentially in the base, that is, one cavity is located downstream of the other cavity, or they can be arranged in parallel, that is, the inhaled flow reaches the cavity essentially simultaneously.

Although the inhaler can be linear, having successive cavities mounted along a straight line, it can also be configured accordingly as having a generally annular shape. In particular, in accordance with at least one illustrative embodiment of the invention, the base is made as a circular disk, and the cavities are made sequentially arranged in a circle or in a circular path around the disk. Thus, when the drug is inhaled from one cavity, the base rotates relative to the mouthpiece or nasal adapter of the inhaler to discretely move the inhaler to the next cavity.

In accordance with at least a second aspect of the invention, there is provided a method of operating an inhaler comprising a base having several drug-containing cavities that can be successively moved to the dispensing position of the inhaler, the inhaler being provided with a foil that is attached to the base for sealing the drug on one side. means inside the corresponding associated cavities, and the opposite side is attached to the separating elements, each of which The latter is associated with the corresponding cavity and is intended to separate the foil from this cavity. The method includes moving the separating element away from the associated cavity to ensure that the sealing foil is separated from the cavity, which, in turn, is opened, trapping the drug in the fluid stream from the opened cavity, when said open cavity is in the indicated distribution position, return displaced separation element to close the associated cavity and discrete movement of the base to move the next cavity to the specified position distribution phenomena.

The separation of the foil from the cavity by moving the separation element can, for example, be performed before the indicated discrete movement. Another alternative is to perform separation after the indicated discrete movement. The aforementioned method can be used in inhalers, as discussed in connection with the first aspect of the invention, that is, when the inhalers have dividing elements that act as elements of the formation of a flow channel for their associated cavities and for adjacent cavities. The aforementioned method can, however, also be used in inhalers in which each dividing element acts only as an element of the formation of a flow channel for the associated cavity, which it closes. For example, between the dividing elements, dividing walls can be provided which extend perpendicularly upward from the base. Such dividing walls will form the side walls of the flow channel formation, while the raised dividing element forms the upper wall of the flow channel formation. Assembled together, the separation walls can be mounted on the foil covering (or intended for later closing) the cavity in a manner that causes weakening in the foil, thereby establishing the formed portions of the foil between the separation walls.

In accordance with at least one illustrative embodiment of the invention, said movement includes the application of a force that repels the spacer member from the cavity. Alternatively, said movement includes the application of a force that moves the spacer member away from the cavity.

According to at least one illustrative embodiment of the invention, the method includes, after said sliding of the separation element, aligning it so that the side of the separation element facing the hole of the cavity becomes parallel to the hole of the cavity. Thus, referring to the terminology used in the discussion of the first aspect of the invention, the first wall is aligned parallel to the cavity and facing it, and this cavity is located below the first wall, so this wall is able to form the upper wall of the formation of the flow channel to the specified associated cavity, when it is raised from the cavity, and the specified upper wall of the formation of the flow channel parallel to the plane formed by the rim of the hole of the cavity. This makes it possible to move the fluid stream substantially parallel to the plane formed by the rim of the opening of the cavity, wherein such a fluid stream does not substantially enter the cavity, but instead creates a vortex or vortex in the cavity, which causes the drug to leave the cavity and joins the fluid stream. Depending on the required characteristics of the flow channel, there are other alternatives for performing such parallel alignment of the separation element and the opening of the cavity. For example, it is possible to provide for the location of the reverse side of the moved separation element at an angle of inclination (except for a zero angle, which corresponds to a parallel arrangement) to a plane formed by the rim of the cavity opening. This makes it possible to direct the fluid flow at least partially into the cavity, or to increase or decrease the flow rate, or to obtain other possible effects.

It should be understood that the second aspect of the invention encompasses any embodiments or any features described in connection with the first aspect of the invention, so long as these embodiments or features are compatible with the method of the second aspect.

The inhaler may contain various medications and / or bioactive inhalation agents.

The bioactive agent may be selected from any therapeutic or diagnostic agent. For example, it can be selected from the group of antiallergic drugs, bronchodilators, bronchoconstrictors, pulmonary surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, anticholinergics, mast cell inhibitors, antihistamines, anti-inflammatory drugs, anticancer drugs, anticancer drugs, anti-tumor drugs, agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisensory agents PTS proteins, peptides and combinations thereof.

Examples of specific formulations that may be included in a drug-containing cavity in accordance with the invention include mometasone, ipratropium bromide, tiotropium and its salts, salmeterol, fluticasone propionate, beclomethasone dipropionate, reproterol, clenbuterol, rrofleponide, sodium chromoglucromide salt , flunisolid, budesonide, formoterol fumarate dihydrate, Symbicort (TM) (budesonide and formoterol), terbutaline, terbutaline sulfate, salbutamol base and sulfate, phenoterol, 3- [2- (4-Hydroxy-2-oxo-3H- 1,3-benzot azole-7-yl) ethylamino] -N- [2- [2- (4-methylphenyl) ethoxy] ethyl] propane sulphonamide, hydrochloride. All of the above formulations may be present in free base form or as pharmaceutically acceptable salts, as is known in the art.

Combinations of drugs may also be used, for example, formoterol / budesonide; formoterol / fluticasone; formoterol / mometasone; salmoterol / fluticasone; formoterol / tiotropium salts; zafirlukast / formoterol, zafirlukast / budesonide; montelukast / formoterol; montelukast / budesonide; loratadine / montelukast and loratadine / zafirlukast.

Further combinations include tiotropium and fluticasone, tiotropium and budesonide, tiotropium and mometasone, mometasone and salmoterol, formoterol and rofleponide, salmoterol and budesonide, salmoterol and rofleponid, and tiotropium and rofleponid.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an inhaler made in accordance with at least one illustrative embodiment of the invention, wherein a portion of the inhaler casing is shown cut to illustrate some internal details.

Figure 2 schematically illustrates the installation of the spacer elements on a base having a large number of cavities.

Figa-3e schematically illustrate a sequence of operations that includes the separation of the foil from the cavity that it closes, and the distribution of the medicinal product contained in the cavity.

Figures 4a-4e schematically illustrate an alternative sequence of operations that includes separating the foil from the cavity that it closes and dispensing the drug contained in the cavity.

Figures 5a-5c schematically illustrate a sequence that substantially corresponds to the sequence illustrated in Figures 3a-3c, but with a view against the direction of fluid flow.

FIG. 6 schematically illustrates an illustrative embodiment as an alternative to that illustrated in FIG. 6a.

DETAILED DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic view of an inhaler 2, with a portion of the casing 4 of the inhaler shown cut out to illustrate some internal details. The casing 4 surrounds the base 6, having a large number of cavities 8, hermetically sealed with foil 10 (see Figure 2). For each cavity 8, a dividing element 12 is attached on top of the foil. The actuator 14, illustrated here as having a lever, extends from the central location of the inhaler 2. The actuator 14 is configured to simultaneously interact with one dividing element 12 and move it upward to separate the foil from the cavity 8 under the separation element 12. Thus, the drug contained in the cavity 8 can be entrained in the fluid stream that the user inhales. In this example, the fluid stream is an air stream, with the drug leaving the inhaler 2 through the mouthpiece 16.

The actuator 14 can be manually actuated by pushing, pushing, turning, etc. buttons, levers, etc., made on the casing 4 of the inhaler (not shown), or can be initiated by the inhalation of the user, in which case he will be fixed by a trigger sensitive to air flow (not shown).

Before, during or after inhalation, the base 6 rotates (moves discretely) to bring the next cavity 8 to the desired position. This can be done in various ways, such as using a standard lever on the casing 4. Another alternative may be to use a connection between the base 6 and the mouthpiece cover, the removal (or replacement) of the mouthpiece cover causing the base 6 to move one step discretely to of the next cavity 8. Another alternative is to use a respiration-initiated mechanism, which leads to discrete movement of the base 6 by one step.

Inhaler 2 may suitably comprise a structure that provides moisture protection, such as, for example, a moisture absorbing receiver described in international patent application No. 2006/000758, or any other suitable alternative for incorporating a moisture absorbing material.

Figure 2 schematically illustrates the installation of the separation elements 12 on the base 6, having a large number of cavities 8. The base 6 as a whole has an annular and circular shape, with the cavity 8 are arranged in a circle along the base. When a powdered drug is placed in the cavity, a foil 10 can be placed on the base 6 to seal the cavities 8, and then a large number of separation elements 12 are placed on top of the foil 10 to align and line each separation element 12 with the corresponding cavity 8. As alternatives, a large number of spacer elements 12 may first be attached to the foil, and then said foil is attached to the base 6 to seal the cavity 8. Hermetic Alternatively, perforation or loosening can be performed in the foil 10 to limit the foil, which is easily separable from the cavity when the spacer element is raised from the base. Such perforations or weakenings can, for example, be performed at a separate manufacturing step, but, alternatively, can be obtained when the foil is attached to the base and / or the spacer elements, if the base and / or spacer elements have structural elements that create perforations or weakening during the joining phase. The finished assembly of the base 6, the foil 10 and the separation elements 12 can then be inserted into the casing 4 or some other retaining structure, for example, as disclosed in international patent application No. 2006/000758.

Most of the elements of the inhaler 2, such as the base 6, the separation elements 12 and the actuator 14 are suitably made of plastic, such as a polymer, however other materials, such as metal or ceramic, are also possible alternatives.

Figa-3e schematically illustrate a sequence of operations that includes the separation of the foil 110 from the cavity 108, which it closes, and the implementation of the distribution of the medicinal product contained in the cavity 108.

Fig. 3a is a section through a cavity 108 at the base 106, the cavity 108 containing a powdered medicament 118 and sealed with foil 110. The foil 110 is attached by any suitable type of adhesion, welding, gluing, etc. to the base region 106 that surrounds the rim of the cavity opening. The spacer member 112 is attached by any suitable type of adhesion, welding, gluing, etc. to the foil 110. In the continuation of the direction of the flow channel, the separation element 112 covers the entire foil 110, while the direction of the flow channel is illustrated by arrows in Fig.3d. Thus, the contact area between the separating element 112 and the foil 110 is larger than the contact area between the foil 110 and the base, providing the ability to achieve a greater bonding force between the separating element 112 and the foil 110, compared with the bonding force between the foil 110 and the base 106.

The separation element 112 comprises a lower part 122 and an upper part 124, which can be made in the form of one part or as two separate parts connected together. Between the lower part 122 and the upper part 124 there is a space 126. The space 126 is made in the form of a pocket that is open to the center of the inhaler, that is, to the actuator 114. The upper part 124 has a bottom side 128, which faces the space 126 and the lower part 122, wherein said underside 124 is somewhat curved to allow the actuator 114 to tilt and align the spacer 112, as will be explained with reference to FIGS. 3b-3c. In the position illustrated in FIG. 3a, the actuator 114 has been inserted substantially horizontally into the space 126.

When the end 130 of the actuator 114 is rotated up to a certain angle, it interacts with the lower side 128 of the upper part 124 at the first point P1, applying a lifting force thereto, as illustrated in FIG. 3b. This causes the spacer member 112, together with the attached seal or foil 110, to rise, pivoting about the pivot point 132 at the end of the foil / base interface downstream of the cavity 108.

Then, the drive 114, with a maintained angle of inclination, advances forward in the direction of flow, that is, further into the pocket-shaped space 126. This leads to the fact that the foil 110 and the separating element 112 attached thereto are completely separated from the base 106. Deeper into the pocket-shaped space 126, the lower side 128 is more cut out than at the location of the indicated first point P1 of the lower side 128. When the end 130 of the drive 114 reaches the inner second point P2 of the lower side 128, the spacer 112 has already turned in the other direction, bringing the separated foil 110 into a plane that is parallel to the main plane of the base 106, as illustrated in FIG. 3c. This is due to the curvature of the lower side of the upper part 124. The vertical distance (in this case, for example, the direction from the base 106 to the separating element 112, is vertical) between said first point P1 and said second point P2, which is equal to the vertical distance between those parts drive 114, which make contact with the specified first and second points, respectively, when the drive 114 is located at the desired angle. It should be understood that this is only an illustrative embodiment, and therefore it is possible to use a different curvature of the lower side to obtain a different orientation of the spacer element and the attached foil relative to the base.

As illustrated in FIG. 3d, when the foil 110 is completely separated from the base 106 and the cavity 108 has reached the desired position, the fluid flow can capture the powdered drug 118 from the cavity 108. The direction of the fluid flow is illustrated by arrows, upstream means towards the center of the inhaler 2 relative to the cavity 108, and downstream means radially to the mouthpiece 16 (see Figure 1). A fluid stream may be triggered in response to the inhalation by the user through the nozzle 16. Alternatively, it may be manually actuated by venting the generated pressure in the pressure chamber, which is in communication with the flow channel passing between the raised separation element 112 ( including foil 110) and base 106.

After inhalation, the actuator 114 is removed, and the separating element 112 with the attached foil 110 is again lowered to the base 106 to the return position, which corresponds to its initial position, closing the cavity 108 again, as illustrated in FIG.

Although the actuator 114 is shown in FIGS. 3a-3e to comprise a lever, and the spacer 112 was illustrated to comprise a pocket-shaped space 126 between the upper portion 124 and the lower portion 122, other alternative embodiments are possible in order to move the spacer 112 with the attached foil 110 from the base 106. The illustrated illustrative embodiments are not restrictive in any way, but are included herein for the purpose of explanation only.

4a-4e schematically illustrate a process that includes separating the foil 110 from the cavity 108 that it closes, and dispensing the drug contained in the cavity 108.

Fig. 4a is a section through a cavity 108 in a base 106, on which a cavity 108 is shown containing a powdered drug and a hermetically sealed foil 110. The foil 110 is attached by any suitable type of adhesion, welding, gluing, etc. to the base region 106 that surrounds the rim of the cavity opening. The spacer 112 'is attached by any suitable type of adhesion, welding, gluing, etc. to the foil 110. In the continuation of the direction of the flow channel, the dividing element 112 ′ covers the entire foil 110, while the direction of the flow channel is illustrated by arrows in FIG. Thus, the contact area between the dividing element 112 'and the foil 110 is larger than the contact area between the foil 110 and the base 106, providing the ability to achieve a greater bonding force between the dividing element 112' and the foil 110, compared with the bonding force between the foil 110 and base 106.

The separation element 112 'comprises a lower part and an upper part, which can be made in the form of one part or as two separate parts connected together. The separation element 112 'has an upper surface 140. The upper surface 140 describes a beveled path in a portion that is located towards the center of the inhaler, that is, to the actuator 114'. The actuator 114 'is a hook made with the possibility of placing around the edge of the separation element 112'. When the hook is rotated, this movement causes it to interact with the separation element 112 'with the corresponding inclination and alignment of the separation element 112, as will be explained with reference to Figs. 4b-4c. The drive 114 'comprises an upper end 151 and a lower horse 152.

When the end 152 of the actuator 114 'is rotated up to a certain angle, it interacts with the bottom side 128 of the separation element 112' at the first point P1, applying a lifting force thereto, as illustrated in Fig. 4b. This causes the separation element 112 ′ to rise with the attached seal or foil 110, pivoting about a pivot point at the end of the foil / base interface downstream of the cavity 108.

Then, the actuator 114 'is rotated further for the interaction of the upper end 151 with the beveled path 140. This leads to the fact that the foil 110 and the attached separation element 112' are completely separated from the base 106. When the end 151 of the actuator 114 'reaches the inner second point P2 lower side 128, the spacer 112 'has already rotated in the other direction, bringing the separated foil 110 into a plane that is parallel to the main plane of the base 106, as illustrated in FIG. 4 c. This is due to the curvature of the beveled portion of the top parts 124. The vertical distance (in this case, vertical, for example, is the direction from the base 106 to the dividing element 112 ') between the indicated first point P1 and the indicated second point P2, which is equal to the vertical distance between those parts of the drive 114' that make contact with the specified first and second points, respectively, when the actuator 114 'is located at the desired angle. It should be understood that this is only an illustrative embodiment, and therefore it is possible to use a different curvature of the beveled portion to obtain a different orientation of the spacer element and the attached foil relative to the base.

As illustrated in FIG. 4d, when the foil 110 is completely separated from the base 106 and the cavity 108 has reached the desired position, the fluid flow can capture the powdered drug 118 from the cavity 108. The direction of the fluid flow is illustrated by arrows, upstream means towards the center of the inhaler 2 relative to cavity 108, and downstream means radially to the mouthpiece 16 (see Figure 1). A fluid stream may be triggered in response to the inhalation by the user through the nozzle 16. Alternatively, it may be manually actuated by venting the generated pressure in the pressure chamber, which is in communication with the flow channel between the raised separation element 112 ′ (including foil 110) and base 106.

After inhalation, the actuator 114 is removed, and the separating element 112 'with the attached foil 110 is again lowered to the base 106 to the return position, which corresponds to its initial position, again closing the cavity 108, as illustrated in Fig.4E.

Although FIGS. 4a-4e show the actuator 114 'comprising a hook and the spacer 112' is illustrated containing a beveled portion 140 at the top located toward the center of the inhaler, other alternative embodiments are possible to move the spacer 112 'with the attached foil 110 from the base 106. The illustrated illustrative embodiments are not restrictive in any way, but are included herein for the purpose of explanation only.

5a-5c schematically illustrate a sequence that substantially corresponds to the sequence illustrated in FIGS. 3a-3c, however, when viewed against the direction of fluid flow. In order to facilitate understanding of the subsequent discussion, we will make reference to the first cavity 208a, the second cavity 208b, and the third cavity 208c. These cavities are covered by the corresponding first, second, and third parts 210a-210c of the foil and the corresponding first, second, and third separation elements 212a 212s Powdered drug in the first cavity 208a is shown already trapped in the fluid stream after the associated separation element 212a has removed the closing foil 210a from the cavity 208a. As illustrated in FIG. 6a, the release member 212a with the attached foil 210a has returned to the base 206 to close the first cavity 208a. The second cavity 208b is still hermetically sealed with foil 210b and is next in line for the next drug for inhalation. The third cavity 208c will be in line for inhalation after the distribution of the drug from the second cavity 208b has been completed.

Fig. 5b illustrates an upward rotation of the second spacer member 212b and the attached foil 210b that close the second cavity 208b, thereby corresponding to the action illustrated in Fig. 3b.

Fig. 5c illustrates a second cavity 208b that has been fully opened since the spacer 212b has completely removed the foil 210b from the base 206 and the second cavity 208b, thereby corresponding to the position illustrated in Fig. 3c. In this position, the powdered drug may be entrained in a fluid stream passing through or entering the second cavity 208b. The upward flow channel is bounded by a second foil 210b attached to the second spacer element 212b and thus is now considered part of the second spacer element 212b. The lower side of this separation element 212b and the attached foil 210b thus form a first flow channel formation wall. The first separation element 212a and the third separation element 212c have a side wall 236a, 236c forming a flow channel, each for the same flow channel.

Thus, it should be noted that different walls of the spacer element will be used to form flow channels for various cavities. One wall is used for the associated cavity below the separation element, and other walls are used for adjacent cavities. Thus, the second separation element 212b also has a lateral second wall 236b, which has already been used to form a flow channel for capturing the drug from the first cavity 208a. In addition, the second dividing element 212b has a lateral third wall 236b ', which is used to form the flow channel when the drug must be captured from the third cavity 208c.

FIG. 6 schematically illustrates an illustrative embodiment as an alternative to that illustrated in FIG. 4a. Between adjacent dividing elements 312, dividing walls 300 are provided. Dividing walls 300 extend perpendicularly upward from the foil 310 on the base 306. Thus, when the dividing element 312 is moved away from the base 306, two side dividing walls 300 will contribute to the formation of the flow channel, while the displaced the spacer 312 will form the upper wall of the formation of the flow channel.

Claims (19)

1. An inhaler containing:
a base having sealed cavities containing the drug, which are arranged to move sequentially to the dispensing position of the inhaler,
foil, which is attached to the base on one side for hermetically closing the medicine inside the corresponding associated cavities, and on the opposite side is attached to the separation elements, each of which is associated with the corresponding cavity and is designed to separate the foil from this cavity,
a drive configured to act on the spacer element associated with the cavity currently in the dispensing position, thereby moving this spacer element to a distant position in which the spacer element is spaced from the cavity so that the sealing foil is separated from cavity, which, thus, opens up with the possibility of capturing the contained medicinal product in the fluid stream,
however, when the separating element is in a distant position, the attached foil at least partially limits the flow channel for the drug captured from the cavity, and
however, the separating element has a return position in which the separating element with the attached foil is moved back to close the associated cavity. 2. The inhaler according to claim 1, in which between each pair of adjacent dividing elements there is a dividing wall that extends perpendicular upward from the base. 3. The inhaler according to claim 1 or 2, in which the fastening force between each separating element and the corresponding associated foil is greater than the fastening force between the base and the foil, so that the movement of the separating element from the associated cavity leads to the separation associated with it foil from the base. 4. The inhaler according to claim 3, in which the contact surface between the separation element and the associated foil is larger than the contact surface between this foil and the base. 5. The inhaler according to claim 3, in which each foil contains a first coating layer to which the base is attached, and a second coating layer to which the separation element is attached, the tensile strength of the second coating layer being greater than the tensile strength of the first layer coverings. 6. The inhaler according to claim 3, in which the stiffness of each separating element is substantially greater than the stiffness of the foil associated with it, while the separating element provides the ability to move the foil as a whole. 7. The inhaler according to claim 1 or 2, in which the specified base has the shape of a round disk, and the cavity is arranged sequentially in a circle around the disk. 8. An inhaler containing:
a base having sealed cavities containing the drug, which are arranged to move sequentially to the position of the distribution of the inhaler,
foil, which is attached to the base on one side for hermetically closing the medicine inside the corresponding associated cavities, and on the opposite side is attached to the separation elements, each of which is associated with the corresponding cavity and is designed to separate the foil from this cavity,
a drive configured to act on the spacer element associated with the cavity currently in the dispensing position, thereby moving this spacer element to a distant position in which the spacer element is spaced from the cavity so that the sealing foil is separated from cavity, which, thus, opens up with the possibility of capturing the contained medicinal product in the fluid stream,
moreover, the cavity is made with the possibility of stepwise movement relative to the drive, and
however, the separating element has a return position in which the separating element with the attached foil is moved back to close the associated cavity. 9. The inhaler of claim 8, in which when the separation element is in a distant position, the attached foil at least partially limits the flow channel for the drug captured from the cavity. 10. An inhaler according to any one of claims 8 or 9, in which a separation wall is made between each pair of adjacent separation elements, which extends perpendicularly upward from the base. 11. The inhaler according to any one of claims 8 or 9, in which the fastening force between each separating element and the corresponding associated foil is greater than the fastening force between the base and the foil, so that the movement of the separating element from the associated cavity leads to the separation of the associated with it foil from the base. 12. The inhaler according to claim 11, in which the contact surface between the separation element and the associated foil is larger than the contact surface between this foil and the base. 13. The inhaler according to claim 11, in which each foil contains a first coating layer to which the base is attached, and a second coating layer to which the spacer element is attached, the tensile strength of the second coating layer being greater than the tensile strength of the first layer coverings. 14. The inhaler according to claim 11, in which the stiffness of each separating element is substantially greater than the stiffness of the foil associated with it, while the separating element allows the foil to move as a whole. 15. The inhaler according to any one of paragraphs.8 or 9, in which the specified base has the shape of a circular disk, and the cavity is arranged sequentially in a circle around the disk. 16. The method of operation of an inhaler containing a base having cavities containing a drug, which are arranged to move sequentially to the dispensing position of the inhaler, the inhaler being provided with a foil that is attached to the base with one side for hermetically closing the drug inside the corresponding cavities, and the opposite side is attached to the separation elements, each of which is associated with a corresponding cavity and is designed to pouring foil from this cavity, the method includes:
moving the separating element from the associated cavity with the separation of the sealing foil from the cavity, which becomes open,
capture in the fluid stream of the drug from the opened cavity, when the specified open cavity is in the specified position for the distribution,
the return of the moved separation element to close the associated cavity,
discrete displacement of the base for moving the next cavity to the specified distribution position. 17. The method according to clause 16, in which during the specified movement apply a force that pushes the separating element from the cavity. 18. The method according to clause 16 or 17, in which after the specified movement of the separation element, it is aligned so that the side of the separation element facing the hole of the cavity is located at a predetermined angle relative to the hole of the cavity. 19. The method according to clause 16 or 17, in which after the specified movement of the separation element, it is aligned so that the side of the separation element facing the hole of the cavity is parallel to the hole of the cavity.

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